Phase II Study With Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Completed
• CT.gov ID: NCT00204659
• Collaborator: Hoffmann-La Roche (Industry)
• Enrollment: 30
• Locations: 5
• Duration (Months): 66.1
• Patients Per Site: 6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The optimal treatment of primary gastric diffuse large B-cell lymphoma (PG-DLBCL) has not yet been defined. In most circumstances, a stomach-conserving approach is favored, but the role of radiotherapy is still a matter of debate. Recently, Rituximab along with full-dose CHOP chemotherapy has been shown to improve the outcome in elderly patients with nodal DLBCL. However, no data are available with such a therapy in patients with PG-DLBCL. Therefore, in March 2003, we initiated an ongoing, prospective, multicenter phase II study in patients with PG-DLBCL with 6 to 8 cycles of Rituximab (R; 375 mg/m2) plus CHOP-21 in order to evaluate the safety and efficacy of this approach.

Condition or Disease	Intervention/Treatment	Phase
Primary Gastric Diffuse-Large B-Cell Lymphoma	Drug: Rituximab + CHOP chemotherapy	Phase 2

Detailed Description

see above

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study With Rituximab and CHOP in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma
• Study Start Date: Mar 1, 2003
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Outcome Measures

Primary Outcome Measures

1. Complete remission rate [at end of chemo-immunotherapy]

2. Progression-free survival [at 2 and 5 years]

Secondary Outcome Measures

1. Overall survival [at 2 and 5 years]

2. Toxicity [after chemo-immunotherapy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age > 18 years

• Histologically confirmed primary gastric CD20+ DLBCL

• Written informed consent

• ECOG 0-2

Exclusion Criteria:

• Secondary aggressive Non-Hodgkin's lymphoma involving the gastric area

• HIV positive patients

• Severe organ dysfunction

• Life expectancy of less than 3 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zentralklinikum Augsburg	Augsburg		Germany	86156
2	University of Giessen	Giessen		Germany	35392
3	Klinikum Reutlingen	Reutlingen		Germany
4	University of Tubingen	Tuebingen		Germany	72076
5	Schwarzwald-Baar Clinic	Villingen-Schwenningen		Germany	78050

Sponsors and Collaborators

• University Hospital Tuebingen
• Hoffmann-La Roche

Investigators

• Principal Investigator: Wolfram Brugger, M.D., Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00204659
• Other Study ID Numbers: 64-03
• First Posted: Sep 20, 2005
• Last Update Posted: Oct 20, 2008
• Last Verified: Sep 1, 2008

• Keywords provided by , ,: Rituximab; CHOP; DLBCL; gastric lymphoma
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Rituximab

Study Results

No Results Posted as of Oct 20, 2008